improvement strategies utilizing bundles and protocols · • the development of reliable clinical...

Improvement Strategies Utilizing Bundles and Protocols

Peter Cherouny, MD University of Vermont

Division of Maternal-Fetal Medicine

Objectives

1. Introduce and define the concept of the bundles

2. Use the perinatal bundles as examples of reliable design

3. Results

Learning Objectives

At the end of the presentation, the participant: • Will be able to state what a clinical bundle represents • Will be able to describe the induction and augmentation

bundles • Will be able to implement bundles in their work setting Disclosures Dr. Cherouny has no conflict of interest to disclose.

Why focus on perinatal care? • Good science exists

• Significant variability in process.

– Care is provider driven rather than standardized. – This autonomous practice focus contributes to the

unreliable delivery of care.

Quality Care in Obstetrics Why is this important now

Why focus on perinatal care?

2007 4,317,119 births in US

Birth trauma 6.3-7.3/1000 estimated 50-90% are preventable

What does that mean for NY?

New York State 1600-1900/yr 800-950 preventable

What does that mean for US?

27,000-32,000 injured babies total 13,500-16,000 preventable

What do we want to do?

Prevent the preventable Defend the unpreventable

What is Idealized Design of Perinatal Care?

• The development of reliable clinical processes to manage labor and delivery (Perinatal Bundles)

• The use of principles that improve safety (i.e., preventing, detecting, and mitigating errors)

• The establishment of prepared and activated care

teams that communicate effectively with each other and with mothers and families 11

Reasons for the Reliability Gap In Healthcare

• Communication – 84% of sentinel events reported to JCAHO involving

fetal/infant adverse events cited communication among care providers as the primary factor

JCAHO. Preventing infant death during delivery. Sentinel event

alert No. 30. 2004.

What is Reliability?

• “Reliability is failure free operation over time.” David Garvin Harvard Business School

What is Reliability?

Forbidden Behavior

The Reliability Design Strategy

• Prevent initial failure

– intent and standardization function

• Identify failure (defects) and mitigate – Redundancy function

• Measure and then communicate learning from defects

– Redesign function

Why Standardize?

• Contributes to building an infrastructure (who does what, when, where, how and with what)

• Support training and competency testing to sustain the process

• Achieve front line articulation of key processes by staff

• Allows the appropriate application of Evidence Based Medicine consistently

• Feedback about errors and application of learning to design is possible

The Clinical Bundle as Standardization

What is a Clinical Bundle

• A group of clinical events that should happen every time a given

process occurs • Individual elements based on solid science • Emphasis initially on process rather than outcome • Based on failure modes • Eventual endpoint is outcome improvement

What is a Clinical Bundle

• Bundle example with your life on the line

• Into Thin Air by Jon Krakauer

– Assault on Everest, Spring, 1996

Assault on Everest Summit Hard and Fast Rules

• Acclimatization at altitude

• Work together

• Cannot assist someone on the ascent

• Fixed turn around time

Assault on Everest Summit Summit Bundle

• Acclimatization at altitude

• Work together

• Standard acclimatization techniques

– # days and at what altitude • Work together

– # days and at what altitude

• Practice team work (between and among teams)

– # days and at what altitude

• Practice team work (between and among teams)

• No “short-roping” on the ascent – No assisting with climbing on the ascent

– # days and at what altitude • Practice team work (between and among

teams) • No “short-roping” on the ascent

– No assisting with climbing on the ascent • Turn around time fixed and honored

– (1 PM for most groups)

Assault on Everest Summit Summit Bundle Compliance

• All teams acclimatized but there was no standard • Teams refused to cooperate on timing through

Hilary’s Step (one person rope) • Some climbers were assisted on the ascent as it was

felt they had to summit on this climb • Turn around time was set but not honored

– Last summit was about 5 PM

Assault on Everest Summit Result

• Experienced leader; summits at 3PM • Less experienced leader; assisted two climbers

up • Inexperienced leader; split group up with one

climber summiting at 5 PM

Assault on Everest Summit Result

• Eleven Deaths • Survivors

– PTSS – Marital problems – Work problems

Mindful Practice

• It is not enough to do your best you must know what to do and then do your best

• W. Edwards Deming

Quality Care in Obstetrics

• Pitocin Bundles as standardization of care – Developing the Bundles

Quality Care in Obstetrics Birth Trauma

• Causation – Large fetuses – Operative vaginal deliveries (esp midpelvic &

combined) – Vaginal breech delivery – Inappropriate use of pitocin – Abnormal/excessive traction – Inadequate assessment of fetal status

• Prevention – Don’t deliver large fetuses – Don’t do Operative vaginal deliveries – Don’t do Vaginal breech delivery – Don’t use pitocin – Don’t pull too hard – Interpret fetal status perfectly

• Prevention – Practice Dermatology

Quality Care in Obstetrics Birth Trauma and Pitocin

combined) – Vaginal breech delivery – Inappropriate use of pitocin (tachysystole) – Abnormal/excessive traction – Inadequate assessment of fetal status

• Pitocin is involved in over 50% of the situations leading to birth trauma

• Prevention of Pitocin Related Trauma – Identify large babies – Don’t do midpelvic deliveries when macrosomia is

suspected – Limit vaginal breech delivery – Identify and respond to tachysystole – Avoid abnormal/excessive traction – Interpret fetal monitor by consensus guidelines

Quality Care in Obstetrics Pitocin Use

• Use Pitocin Safely and Effectively

– Know everything about the drug – Have established protocols and use them

Requirements for elective labor induction • Assessment of gestational age • Monitoring fetal heart rate for reassurance • Monitoring uterine contractions for tachysystole • Pelvic assessment

Quality Care in Obstetrics Elective Labor Induction-Requirements

Assessment of gestational age • Confirmation of Term Gestation • Iatrogenic prematurity is unacceptable and

indefensible

Confirmation of Term Gestation

• Fetal heart tones have been documented for 20 weeks by nonelectronic fetoscope or for 30 weeks by Doppler.

• It has been 36 weeks since a positive serum or urine human chorionic gonadotropin pregnancy test was performed by a reliable laboratory.

• An ultrasound measurement at less than 20 weeks supports gestational age of 39 weeks or greater.

• Amniocentesis and documentation of fetal maturity

ACOG Practice Bulletin #97, August 2008 46

Confirmation of Term Gestation

• An ultrasound measurement at less than 20 weeks supports gestational age of 39 weeks or greater. – Ultrasonography may be considered to confirm menstrual dates

if there is a gestational age agreement within 1 week by crown–rump measurements obtained in the first trimester

– An ultrasound obtained in the second trimester at up to 20 weeks by multiple biometeric parameters confirms the gestational age of at least 39 weeks within 10 days.

ACOG Practice Bulletin #97, August 2008 47

Monitoring fetal heart rate for reassurance • Reassuring Fetal Status – use a common language (NICHD) • Personnel familiar with the effects of uterine stimulants on

the fetus • Physician capable of performing a cesarean delivery should

be readily available and responds when asked

What is Tachysystole > 5 contractions in 10 minutes Contractions persistently lasting greater than 2 minutes < 60 seconds baseline tone between contractions Tachysystole associated with fetal compromise not necessary

Monitoring uterine contractions for tachysystole Personnel familiar with the effects of uterine

stimulants Monitoring fetal heart rate and uterine contractions

is recommended as for any high-risk patient in active labor

Requirements for elective labor induction Assessment of gestational age Monitoring fetal heart rate for reassurance Monitoring uterine contractions for tachysystole Pelvic assessment

Pelvic assessment • Cervical evaluation

– Bishop’s Score

• Fetal presentation and size • Clinical Pelvimetry

Requirements for elective labor induction Assessment of gestational age Monitoring fetal heart rate for reassurance Monitoring uterine contractions for tachysystole Pelvic assessment

Elective Labor Induction Bundle Assessment of gestational age Monitoring fetal heart rate for reassurance Monitoring uterine contractions for tachysystole Pelvic assessment

Elective Labor Induction Bundle Confirmation of Fetal Maturity Monitoring fetal heart rate for reassurance Monitoring uterine contractions for tachysystole Pelvic assessment

Elective Labor Induction Bundle Gestational age > 39 weeks Monitoring fetal heart rate for reassurance Monitoring uterine contractions for tachysystole Pelvic assessment

Elective Labor Induction Bundle Gestational age > 39 weeks Category I EFM Monitoring uterine contractions for tachysystole Pelvic assessment

Elective Labor Induction Bundle Gestational age > 39 weeks Category I EFM Absence of tachysystole with increases in

pitocin/Response to tachysystole Pelvic assessment

Elective Labor Induction Bundle Gestational age > 39 weeks Category I EFM Absence of tachysystole with increases in

Quality Care in Obstetrics Augmentation-Requirements

Augmentation Bundle Gestational age > 39 weeks Category I EFM Absence of tachysystole with increases in

Augmentation Bundle Estimated fetal weight Category I EFM Absence of tachysystole with increases in

Augmentation Bundle Estimated fetal weight Category I and some Category II EFM Absence of tachysystole with increases in

Perinatal Care and IHI Perinatal Bundle

• Results – Measure, Measure, Measure

Seton Hospital Alpha Sites Birth Trauma

Seton Medical Center Team

Quality Care in Obstetrics Preventing Trauma with Vacuum Delivery

• Preliminary considerations – Consider alternative management – High chance of success – Exit strategy prepared – Prepared patient

• Informed consent

– Resuscitation team available

• Technical considerations – Fetal parameters known and considered

• EFW, Station, Position

– Application time and pop-offs limited – Torque in direct line of birth canal

• No rocking movements

• Bundle Components – Individual components supported by science – Required to be performed for every patient, every

time – Bundle compliance measured by fulfilling all parts

of the bundle – Focus on system

• Vacuum Bundle – Alternative labor strategies considered – Prepared patient

• Informed consent discussed and documented

– High probability of success • EFW, fetal position and station known

– Maximum application time and number of pop-offs predetermined

– Exit strategy available • Cesarean and resuscitation team available

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